Dr. Qian Li came to NCCIH in 2012. She is a biostatistician in the Office of Clinical and Regulatory Affairs, where she provides advice on study design and analysis of projects within the NCCIH portfolio of clinical grants. Her work currently focuses on statistical methodologies implemented for integrative health research, and her primary research interest is in studying methodologies for biomarker evaluation.

Prior to joining NCCIH, Dr. Li was a statistics team leader within the Office of Translational Sciences at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). During her 14-year tenure at the FDA, Dr. Li worked with a broad spectrum of therapeutic areas including anti-inflammatory, ophthalmic, special pathogen, dental, dermal, pulmonary, and metabolic drug product divisions. Her expertise was also applied to areas of generic drug evaluation and drug safety evaluation. She has extensive experience in data mining the FDA adverse event reporting system and product quality evaluation. While at the FDA, she was a member of CDER’s Regulatory Science and Review Enhancement Committee and Advanced Scientific Education Committee. Prior to the FDA, Dr. Li was a senior statistician at Novartis. Her previous research activities have been in the areas of collective evidence, meta-analysis, non-inferiority, and drug safety evaluation.

Dr. Li obtained her doctoral degree from the Department of Biostatistics at Harvard School of Public Health, where she received several research prizes and awards, including a National Research Service Award. She earned her M.S. in electrical and computing engineering from Purdue University and her B.S. in Automation and Control Engineering from Tsinghua University in China.